Neoadjuvant Therapy for Stomach Cancer

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Metastatic disease, Solitary kidney, Polyneuropathy, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment approach for stomach cancer, combining chemotherapy and radiation therapy before surgery to potentially shrink tumors and make them easier to remove. The trial tests the safety and effects of specific chemotherapy drugs, such as docetaxel and oxaliplatin, followed by radiation. It seeks participants diagnosed with certain stages of stomach or gastroesophageal junction cancer who are suitable for surgery. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new approach.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the FLOT chemotherapy regimen, which includes fluorouracil, leucovorin, oxaliplatin, and docetaxel, is generally safe and well-tolerated by patients with stomach cancer. It has proven effective in treating advanced stomach cancer, offering a promising option with manageable side effects.

The FOLFOX chemotherapy regimen, which uses oxaliplatin, fluorouracil, and leucovorin, also maintains a good safety record. Studies have found it effective for advanced stomach cancer, with many patients tolerating the treatment well.

For neoadjuvant chemoradiation, which combines chemotherapy with radiation therapy, research indicates that using capecitabine with radiation is safe and tolerable for stomach cancer patients. This treatment helps shrink tumors before surgery, and most patients do not experience severe side effects.

Although these treatments have been well-tolerated in other studies, this trial is in an early phase, focusing mainly on testing safety in humans. Participants might experience some side effects, but these treatments have shown promise in being safe and effective in other research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this neoadjuvant therapy for stomach cancer because it combines multiple treatments to potentially enhance effectiveness. Unlike the typical approach that might use a single form of chemotherapy or radiation, this treatment integrates FLOT or FOLFOX chemotherapy, followed by radiation therapy paired with either fluorouracil or capecitabine, and culminates in surgery. This comprehensive approach aims to shrink tumors more effectively before surgery, possibly improving surgical outcomes and reducing recurrence. The use of capecitabine, an oral medication, offers a more convenient administration compared to traditional IV methods, which can improve patient experience during treatment.

What evidence suggests that this trial's treatments could be effective for stomach cancer?

This trial will evaluate neoadjuvant therapies for stomach cancer, including FLOT chemotherapy, FOLFOX chemotherapy, and neoadjuvant chemoradiation. Research has shown that FLOT chemotherapy, a combination of four drugs (docetaxel, oxaliplatin, leucovorin, and fluorouracil), may extend the lives of patients with locally advanced stomach cancer. Previous studies found that this treatment can improve survival rates and effectively shrink tumors before surgery.

FOLFOX chemotherapy, which uses three drugs (oxaliplatin, fluorouracil, and leucovorin), is another treatment option in this trial. It has proven effective and manageable as an initial treatment for advanced stomach cancer, with patients experiencing longer survival.

Neoadjuvant chemoradiation, involving either fluorouracil or capecitabine before surgery, is also under study in this trial. This approach has shown benefits in increasing survival rates and can significantly shrink the cancer or even make it disappear before surgery. ^{6 7 8 9 10}

Who Is on the Research Team?

Dayssy A Diaz Pardo, MD, MS

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with certain stages of stomach or gastroesophageal junction cancer, who are fit enough for surgery and chemotherapy. They should not have distant spread of cancer, severe neuropathy, or only one working kidney in the radiation area.

Inclusion Criteria

My cancer is early stage and has not spread to lymph nodes.

I am eligible for surgery.

I have had or am recommended to have special scans to check my cancer stage before joining.

Exclusion Criteria

My cancer has spread to distant parts of my body.

My nerve damage does not severely limit my daily activities.

I have only one working kidney that might be affected by radiation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Patients receive FLOT or FOLFOX chemotherapy every 2 weeks for 4 cycles

8 weeks

Neoadjuvant Chemoradiation

Patients undergo radiation therapy in 25 fractions over 5 weeks and receive fluorouracil or capecitabine

5 weeks

Surgery

Patients undergo surgical resection according to tumor location and per surgeon expertise

4-8 weeks after chemoradiation

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Capecitabine
• Docetaxel
• Fluorouracil
• Leucovorin
• Oxaliplatin
• Radiation Therapy
• Surgical Procedure

Trial Overview The study tests if giving chemotherapy (with drugs like docetaxel and oxaliplatin) followed by chemoradiation before surgery can safely shrink tumors in patients with gastric or gastroesophageal junction cancer.

How Is the Trial Designed?

Group I: Treatment (chemotherapy, chemoradiation, surgery) Experimental Treatment 7 Interventions

NEOADJUVANT CHEMOTHERAPY: Patients receive FLOT chemotherapy consisting of docetaxel intravenously (IV) , oxaliplatin IV, leucovorin IV, and fluorouracil IV over 24 hours on day 1 or FOLFOX chemotherapy consisting of oxaliplatin IV and leucovorin IV, and fluorouracil IV continuously over 24 hours on days 1 and 2. Treatment repeats every 2 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. NEOADJUVANT CHEMORADIATION: Within 4 weeks after completing neoadjuvant chemotherapy, patients undergo radiation therapy in 25 fractions over 5 weeks. Patients also receive either fluorouracil IV continuously for 24 hours on days 1-5 or capecitabine orally (PO) twice daily (BID) on days 1-5. Cycles repeat weekly for 5 weeks in the absence of disease progression or unacceptable toxicity. SURGERY: Within 4-8 weeks after neoadjuvant chemoradiation, patients undergo surgical resection according to tumor location and per surgeon expertise.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39400342/

The New Era of Total Neoadjuvant FLOT Therapy for ... Conclusion: Total neoadjuvant therapy with the FLOT x8 protocol corresponds to higher treatment completion rates, a safety profile similar to ...

2. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00427-4/fulltext

Neoadjuvant FLOT versus SOX chemotherapy in locally ... With median follow-up of 65.7 months, both regimens demonstrated comparable long-term survival outcomes. Median overall survival was 61.5 months (95% CI: not ...

3. nature.com nature.com/articles/s41467-020-19965-6

Neoadjuvant FLOT versus SOX phase II randomized ... The results of these studies suggested that the FLOT regimen was beneficial to locally advanced gastric cancer in terms of pathological ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.396

Perioperative chemotherapy with either S-1 or 5- ... Perioperative LOTS shows reasonable therapeutic efficacy and survival as compared with FLOT in patients with locally advanced gastric/GEJ cancer.

5. ecancer.org ecancer.org/en/journal/article/1705-outcomes-of-locally-advanced-gastric-and-gastroesophageal-adenocarcinoma-cancers-treated-with-neoadjuvant-flot-in-a-tertiary-care-hospital-in-pakistan/pdf

Outcomes of locally advanced gastric and ... Background and aim: Docetaxel, oxaliplatin, leucovorin and 5-fluorouracil (FLOT) may improve overall survival (OS) in patients with locally ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37006064/

Fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) ... FLOT is a highly active option in the first-line treatment of metastatic gastric cancer, with a favorable safety profile.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06028737

Total Neoadjuvant FLOT Chemotherapy in Locally ... The main goal of this study is to investigate the proportion of participants with locally advanced gastric and gastroesophageal adenocarcinoma without ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2017.35.15_suppl.4004

Perioperative chemotherapy with docetaxel, oxaliplatin, ... Conclusion: Periop FLOT improved outcome in patients with resectable gastric and GEJ cancer compared to periop ECF/ECX. Clinical trial ...

9. annalsofoncology.org annalsofoncology.org/article/S0923-7534(21)03743-1/fulltext

1405P Efficacy and safety of perioperative FLOT (5-FU, LV, ... We aimed to determine the real-life efficacy and safety of perioperative FLOT regimen in gastric and GEJ cancer patients. Methods. The patients with gastric and ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6693711/

Docetaxel, Oxaliplatin, and 5‐Fluorouracil (DOF) in ... This phase II study evaluated the efficacy and toxicity of docetaxel, oxaliplatin, and 5‐FU (DOF) for the treatment of metastatic or unresectable gastric or ...